August 16, 2010 - IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections
must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

September 29, 2010 (NOT-OD-11-007) - NIH to Require Use of Updated Electronic Application Forms in 2011. Adobe B1 forms are required for due dates on or after May 8, 2011.

NOTICE: Applications submitted in
response to this Funding Opportunity Announcement (FOA) for Federal assistance
must be submitted electronically through Grants.gov (http://www.grants.gov) using
the SF424 Research and Related (R&R) forms and the SF424 (R&R)
Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application
guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A
registration process is necessary before submission and applicants are highly
encouraged to start the process at least four (4) weeks prior to the grant
submission date. See Section IV.

Purpose.This Funding Opportunity Announcement (FOA) issued by
the Eunice Kennedy Shriver National Institute of Child Health and Human
Development (NICHD) encourages
Small Research Project Grant (R03) applications from institutions/
organizations that propose research
relevant to the basic understanding and development of therapeutic
interventions for currently screened conditions
and “high priority” genetic conditions for which
screening could be possible in the near future. In this FOA, a “high
priority” condition is one for which
the development of an efficacious therapy would make the condition
amenable to newborn screening.The R03 grant mechanism supports different types of projects including pilot and
feasibility studies; secondary analysis of existing data; small,
self-contained research projects; development of research methodology; and
development of new research technology. The R03 is intended to support small research projects that can be carried out
in a short period of time with limited resources.

Mechanism of Support. This FOA will utilize the NIH Small Research Grant
(R03) award mechanism and runs in parallel
with two FOAs of identical scientific scope, PAR-10-230 and PAR-10-232,
that encourage applications under the R01,
R21 mechanisms (FOA numbers/URLs).

Funds
Available and Anticipated Number of Awards. Because the nature
and scope of the proposed research will vary from application to application,
it is anticipated that the size and duration of each award will also vary. The
total amount awarded and the number of awards will depend upon the mechanism
numbers, quality, duration, and costs of the applications received.

Budget and Project Period. Budgets for direct costs of up to $50,000 per year
and a project duration of up to two years may be requested for a maximum of $100,000 direct costs over a
two-year project period.

Research
Strategy Length: The
Research Strategy section of the R03 application may not exceed 6 pages,
including tables, graphs, figures, diagrams, and charts. See Table of Page Limits.

Eligible
Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and
resources necessary to carry out the proposed research are invited to work with
their institution/organization to develop an application for support.
Individuals from underrepresented racial and ethnic groups as well as
individuals with disabilities are always encouraged to apply for NIH support.

Number
of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the
application.

Number
of Applications. Applicants may submit more than one application,
provided that each application is scientifically distinct.

Resubmissions. Applicants may
submit a resubmission application, but such application must include an
Introduction addressing the previous peer review
critique (Summary Statement). See new NIH policy on resubmission (amended)
applications (NOT-OD-09-003, NOT-OD-09-016).

This Funding
Opportunity Announcement (FOA) issued by the Eunice Kennedy Shriver National Institute of Child
Health and Human Development (NICHD is to facilitate
the development of beneficial treatments for infants that have been identified
as having potentially fatal or disabling conditions through newborn
screening. It is important to emphasize that it is the intent of this FOA to
expand the definition of "benefit of
treatment" beyond the traditional medical model.

Demonstrating
the benefits of a treatment is often a primary criterion for inclusion of a
condition on a newborn screening panel; therefore, this FOA not only encourages
research that focuses on conditions for which
screening is currently recommended, but also on those "high priority"
conditions for which screening is not currently recommended but would
significantly benefit from such early identification and treatment.

Background

The intent of
newborn screening is to detect potentially fatal or disabling conditions in
newborns, thereby providing a window of opportunity for early treatment, often
while the child is still asymptomatic. Such early detection and treatment can
have a profound impact on the clinical severity of
the condition in the affected child. If left undiagnosed and untreated, the
consequences of the targeted disorders can be dire, many causing irreversible
neurological damage, intellectual, developmental and physical disabilities,and even death.

In 2006, the American College of Medical Genetics (ACMG) developed newborn screening
guidelines that recommend that all newborn infants be screened for 29
"core conditions" and that 25 secondary conditions identified during the core evaluations be reported. These recommendations
have been accepted by the HHS Secretary's Advisory Committee on Heritable
Disorders in Newborns and Children ((authorized by the Children's Health Act of 2000), and have
been recommended to the Secretary of HHS. Most states
now currently use this or very similar panels for newborn screening.

Expanded
knowledge of the genetic and molecular basis of various conditions, as well as
technological innovations, has paved the way for an increased ability to screen for numerous disorders. Unfortunately, however, the
pace of developing effective treatments lags behind.

Under the
Newborn Screening Saves Lives Act of 2008, the Hunter Kelly Newborn Screening
Research Program (housed within NICHD), the NIH is authorized to carry out, coordinate, and expand research in newborn screening. In 2008, NICHD established the Newborn Screening Translational
Research Network (NBSTRN) Coordinating Center by a contract to ACMG to facilitate the creation of an
infrastructure to support researchers working in the field of Newborn Screening

Research Scope

Applications
submitted in response to this FOA should focus on topic(s) related to the
understanding and/or development of therapeutic interventions for
currently screened conditions and “high
priority” conditions.

The
development of an assay for the target condition must be plausible.

Disorders
to be considered include, but are not limited to: metabolic disorders such
as those of fatty acid oxidation, amino acid, and organic acid metabolism; lysosomal disorders; hemoglobinopathies; congenital
immunodeficiency syndromes; neuromuscular disorders such as Spinal Muscular Atrophy and Duchenne Muscular
Dystrophy; congenital heart disease; and syndromes including Fragile X and Rett, among others.

The
participating Institutes invite investigators with diverse scientific
interests to apply their expertise in basic, behavioral, translational or
clinical research to develop innovative and novel approaches for studying
and treating these conditions. Applicants are
strongly encouraged to contact program staff prior to submitting a
proposal that includes a clinical trial or interventional study in
humans.

Possible areas
of investigation include, but are not limited to:

Basic
investigations to optimize current treatment
regimens or develop new therapeutic interventions for current conditions
and/or "high priority" conditions detectable by newborn
screening.

Comparative
effectiveness studies.

Pre-clinical
testing for safety, toxicity and efficacy in
animal models and other benchmarks required for moving candidate therapies
into Phase I clinical trials.

Development
of multidisciplinary clinical trials of therapeutic protocols for treating
these conditions using validated health outcome markers as study end points.

Clinical
studies including genotype-phenotype analyses that will provide a rational
foundation for the treatment or management of
these conditions.

Studies on
developmental biology and developmental genetics, including epigenetic
alterations linked to a condition, to identify risk markers or potential
therapeutic targets.

Development
of functional biobehavioral markers for outcome
and risk to measure the relationship between health-related quality of
life (HRQoL) and the condition, including markers to measure the impact of
therapeutic interventions. These markers should be validated as measures
of health outcomes and be practical within a
primary care setting.

Development
of health systems outcome research and access to care/services research
pertaining to infants with heritable disorders who are or could be
identified through newborn screening.

Determination of the influence of risk factors such as race,
ethnicity and co-morbid medical conditions associated with treatment
outcomes.

Research on
the natural history of conditions through longitudinal studies or the
analysis of comprehensive clinical data sets to
investigate the progression and inherent variability of a condition, as
well as the long-term health outcomes of those newborns receiving current
and newly developed therapies.

Interventions may be intended to be used
as a single treatment, as an adjuvant to existing
therapies, or as a combination therapy. The specific aims of the project must
be clearly and concisely presented. These should include a clear specification
of the validated primary and major secondary endpoints to be measured with a clear differentiation of the importance of various
endpoints. Use of infrastructure support through the NBSTRN, as needed, is
encouraged (http://www.nbstrn.org).

This FOA will
use the Small Research Grant R03 award
mechanism.The Project Director/Principal
Investigator (PD/PI) will be solely responsible for planning, directing, and
executing the proposed project.

This
FOA uses “Just-in-Time” information concepts see SF424 (R&R)
Application Guide).It also uses the modular as
well as the non-modular budget formats (seehttp://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, a U.S. organization submitting an application with direct costs
in each year of $250,000 or less (excluding consortium Facilities and
Administrative [F&A] costs) should use the PHS398 Modular Budget component.

U.S. applicants requesting more than
$250,000 in annual direct costs and all foreign applicants must complete and
submit budget requests using the Research & Related Budget component.

Because the
nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. Although the financial plans of the NIH Institutes and Centers (ICs)
provide support for this program, awards pursuant to this funding opportunity
are contingent upon the availability of funds and the receipt of a sufficient
number of meritorious applications.

A project period of up
to two years and a budget for direct costs of up to two $25,000 modules, or
$50,000 per year, may be requested (i.e., a maximum of $100,000 over two years
in four modules of $25,000 each). Commensurate Facilities and Administrative
(F&A) costs are allowed.

Facilities
and Administrative (F&A) costs requested by consortium participants are not
included in the direct cost limitation, see NOT-OD-05-004.

Any
individual(s) with the skills, knowledge, and resources necessary to carry out
the proposed research as the PD/PI is invited to work with his/her organization
to develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

More
than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application
for projects that require a “team science” approach and therefore clearly do
not fit the single-PD/PI model. Additional
information on the implementation plans and policies and procedures to formally
allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi.All PDs/PIs must be
registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (seehttp://grants.nih.gov/grants/ElectronicReceipt/preparing.htmfor instructions).

The
decision of whether to apply for a grant with a single PD/PI or multiple
PDs/PIs is the responsibility of the investigators and applicant organizations
and should be determined by the scientific goals of the project. Applications
for grants with multiple PDs/PIs will require additional information, as
outlined in the instructions below. When considering the multiple PD/PI option,
please be aware that the structure and governance of the PD/PI leadership team
as well as the knowledge, skills and experience of the individual PDs/PIs will
be factored into the assessment of the overall scientific merit of the
application. Multiple PDs/PIs on a project share the authority and
responsibility for leading and directing the project, intellectually and
logistically. Each PD/PI is responsible and accountable to the grantee
organization, or, as appropriate, to a collaborating organization, for the
proper conduct of the project or program, including the submission of required
reports. For further information on multiple PDs/PIs, please seehttp://grants.nih.gov/grants/multi_pi.

Number of
Applications. Applicants may submit more than one application,
provided that each application is scientifically distinct. (NIH announcements
should include this sentence unless there are specific deviations from this
rule.)

Resubmissions. Applicants may submit a
resubmission application, but such application must include an Introduction
addressing the previous peer review critique (Summary Statement). Beginning
with applications intended for the January 25, 2009 official submission due
date, all original new applications (i.e., never submitted) and renewal
applications are permitted only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016. Original
new and renewal applications that were submitted prior to January 25, 2009 are
permitted two amendments (A1 and A2). For these “grandfathered”
applications, NIH expects that any A2 will be submitted no later than January
7, 2011, and NIH will not accept A2 applications after that date.

Renewals. The R03 is not renewable.

Small grant support may not be used for
thesis or dissertation research.

Section IV. Application and Submission Information

To
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for
Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions
provided on that Web site.

Registration:

Appropriate
registrations with Grants.gov and eRA Commons must be completed on or before
the due date in order to successfully submit an application. Several of the steps
of the registration process could take four weeks or more. Therefore,
applicants should immediately check with their business official to determine
whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations
must be complete by the submission deadline for the application to be
considered “on-time” (see 3.C.1 for more information about on-time submission).

A one-time registration
is required for institutions/organizations at both:

The
individual(s) designated as PDs/PIs on the application must be registered
also in the NIH eRA Commons. In the case of multiple PDs/PIs, all
PDs/PIs must be registered and be assigned the PI role in the eRA Commons prior to the submission of the application.

Each
PD/PI must hold a PD/PI account in the Commons. Applicants should not
share a Commons account for both an Authorized Organization
Representative/Signing Official (AOR/SO) role and a PD/PI role; however,
if they have both a PD/PI role and an Internet Assisted Review (IAR) role,
both roles should exist under one Commons account.

When
multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization
must be affiliated with that organization. PDs/PIs located at another
institution need not be affiliated with the applicant organization, but
must be affiliated with their own organization to be able to access the Commons.

This
registration/affiliation must be done by the AOR/SO or his/her designee
who is already registered in the Commons.

Both
the PD(s)/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration
process is not sequential. Applicants should begin the registration processes
for both Grants.gov and eRA Commons as soon as their organization has obtained
a DUNS number. Only one DUNS number is required and the same DUNS number must
be referenced when completing Grants.gov registration, eRA Commons registration
and the SF424 (R&R) forms.

1. Request Application Information

Applicants
must download the SF424 (R&R) application forms and SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms
package directly attached to a specific FOA can be used. You will not be able
to use any other SF424 (R&R) forms (e.g., sample forms, forms from another
FOA), although some of the “Attachment” files may be useable for more than one
FOA.

The SF424 (R&R)
Application Guide is critical to submitting a complete and accurate application
to NIH. There are fields within the SF424 (R&R) application components
that, although not marked as mandatory, are required by NIH (e.g., the
“Credential” log-in field of the “Research & Related Senior/Key Person
Profile” component must contain the PD/PI’s assigned eRA Commons User ID).
Agency-specific instructions for such fields are clearly identified in the Application
Guide. For additional information, see “Frequently Asked Questions –
Application Guide,Electronic Submission of Grant
Applications.”

The
SF424 (R&R) application is comprised of data arranged in separate
components. Some components are required, others are optional. The forms
package associated with this FOA inGrants.gov/APPLYwill include all applicable
components, required and optional. A completed application in response to this
FOA will include the following components:

Proposed research should provide special
opportunities for furthering research programs through the use of unusual
talent, resources, populations, or environmental conditions in other countries
that are not readily available in the United States
(U.S.) or that augment existing U.S. resources.

SPECIAL
INSTRUCTIONS

Applications
with Multiple PDs/PIs

When
multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the
"Contact” PI, who will be responsible for all communication between the
PDs/PIs and the NIH, for assembling the application materials outlined below,
and for coordinating progress reports for the project. The contact PD/PI must
meet all eligibility requirements for PD/PI status in the same way as other
PDs/PIs, but has no other special roles or responsibilities within the project team
beyond those mentioned above.

Information
for the Contact PD/PI should be entered on the SF424 (R&R) Cover
component. All other PDs/PIs should be listed in the Research &
Related Senior/Key Person component and assigned the project role of
“PD/PI.” Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included
in the “Credential” field of the Research & Related Senior/Key Person
component. Failure to include this data field will cause the application
to be rejected.

Multiple
PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section
of the Research Plan entitled “Multiple PD/PI Leadership Plan”, must be
included. A rationale for choosing a multiple PD/PI approach should be
described. The governance and organizational structure of the leadership team
and the research project should be described, and should include communication
plans, process for making decisions on scientific direction, and procedures for
resolving conflicts. The roles and administrative, technical, and
scientific responsibilities for the project or program should be delineated for
the PDs/PIs and other collaborators.

If budget allocation
is planned, the distribution of resources to specific components of the project
or the individual PDs/PIs should be delineated in the Leadership Plan. In the
event of an award, the requested allocations may be reflected in a footnote on
the Notice of Award (NoA).

Applications
Involving a Single Institution

When
all PDs/PIs are within a single institution, follow the instructions contained
in the SF424 (R&R) Application Guide.

Applications
Involving Multiple Institutions

When
multiple institutions are involved, one institution must be designated as the
prime institution and funding for the other institution(s) must be requested
via a subcontract to be administered by the prime institution. When submitting
a detailed budget, the prime institution should submit its budget using the Research
& Related Budget component. All other institutions should have their
individual budgets attached separately to the Research & Related Subaward
Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R)
Application Guide for further instruction regarding the use of the subaward
budget form.

When
submitting a modular budget, the prime institution completes the PHS398 Modular
Budget component only. Information concerning the consortium/subcontract
budget is provided in the budget justification. Separate budgets for each
consortium/subcontract grantee are not required when using the Modular budget
format. See Section 5.4 of the Application Guide for further instruction
regarding the use of the PHS398 Modular Budget component.

Prospective
applicants are asked to submit a letter of intent that includes the following
information:

Descriptive title of proposed research.

Name, address, and telephone number of
the PD(s)/PI(s).

Names of other key personnel.

Participating institutions.

Number and title of this funding
opportunity.

Although
a letter of intent is not required, is not binding, and does not enter into the
review of a subsequent application, the information that it contains allows IC
staff to estimate the potential review workload and plan the review.

To
submit an application in response to this FOA, applicants should access this
FOA via http://www.grants.gov/Apply and follow Steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.All attachments must be provided to
NIH in PDF format, filenames must be included with no spaces or special
characters, and a .pdf extension must be used.

3.C. Application Processing

3.C.1
Submitting On-Time

Applications may be submitted on or after the opening date and must be
successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization) on the application due date(s). (See Section
IV.3.A. for all dates.) If an application is not submitted by the due date(s)
and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be
considered “on-time”:

All
registrations must be complete prior to the submission deadline

The
application must receive a Grants.gov tracking number and timestamp (or eRA
help desk ticket confirming a system issue preventing submission) by 5:00 p.m.
local time on the submission deadline date.

Any
system identified errors/warnings must be corrected and the submission process
completed within the “error correction window.”

Submission to Grants.gov is not the last step –
applicants must follow their application through to the eRA Commons to check
for errors and warnings and view their assembled application!

3.C.2 Two Day
Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond.
As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See
NOT-OD-10-123.

Once an application package has been
successfully submitted through Grants.gov,NIH provides
applicants a two day error correction window to correct any eRA
identified errors or warnings before a final assembled application is created
in the eRA Commons. The standard error correction window is two (2) business
days, beginning the day after the submission deadline and excluding weekends and
standard federal holidays. All errors must be corrected to successfully
complete the submission process. Warnings will not prevent the application
from completing the submission process.

Please note that the following
caveats apply:

Initial
application submission must be “on-time.”

The
AOR/institutions is expected to enforce that application changes made within
the error correction window are restricted to those necessary to address
system-identified errors/warnings. NIH may reject any application that includes
additional changes.

Proof of “on-time” submission (e.g., Grants.gov timestamp and
tracking number) and description of all changes made within the window must be
documented in the PHS 398 Cover Letter component of the application.

3.C.3 Viewing
an Application in the eRA Commons

Once any eRA identified errors have been
addressed and the assembled application has been created in the eRA Commons, the PD/PI and
the Authorized Organization Representative/Signing Official (AOR/SO) have two
weekdays (Monday – Friday, excluding Federal holidays) to view the assembled application before it automatically moves
forward to NIH
for further processing.

If everything is
acceptable, no further action is necessary. The application
will automatically move forward to the Division of Receipt and Referral in
the Center for Scientific Review for processing after two weekdays,
excluding Federal holidays.

Prior to the submission
deadline, the AOR/SO can “Reject” the assembled application and submit a
changed/corrected application within the two-day viewing window. This
option should be used if it is determined that some part of the
application was lost or did not transfer correctly during the submission
process, the AOR/SO will have the option to “Reject” the application and
submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to
ensure that the issues are addressed and corrected. Once rejected,
applicants should follow the instructions for correcting errors in Section
2.12 of the SF 424 (R&R) application guide, including the requirement
for cover letters on late applications. The “Reject” feature should also be used if you determine that
warnings are applicable to your application and need to be addressed now.
Remember, warnings do not stop further application processing. If an
application submission results in warnings (but no errors), it will
automatically move forward after two weekdays if no action is taken. Some
warnings may need to be addressed later in the process.

If
the two-day window falls after the submission deadline, the AOR/SO will have
the option to “Reject” the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the
submitted application package (e.g., some part of the application was lost or
didn’t transfer correctly during the submission process). The AOR/SO should
first contact the eRA Commons Helpdesk to confirm the system error,
document the issue, and determine the best course of action. NIH will not
penalize the applicant for an eRA Commons or Grants.gov system issue.

If
the AOR/SO chooses to “Reject” the image after the submission deadline for a
reason other than an eRA Commons or Grants.gov system failure, a changed/corrected
application still can be submitted, but it will be subject to the NIH late policy guidelines and may not be
accepted. The reason for this delay should be explained in the cover letter
attachment.

Both
the AOR/SO and PD/PI will receive e-mail notifications when the application is
rejected or the application automatically moves forward in the process after
two weekdays.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Incomplete applications
will not be reviewed.

There
will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov
acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the
assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be
unreliable, it is the responsibility of the applicant to check periodically on
the application status in the Commons.

The NIH will not accept any
application in response to this FOA that is essentially the same as one
currently pending initial merit review unless the applicant withdraws the
pending application. The NIH will not accept any application that is
essentially the same as one already reviewed. This does not preclude the
submission of an application already reviewed with substantial changes, but
such application must include an “Introduction” addressing the previous
critique. Note that such an application is considered a
"resubmission" for the SF424 (R&R).

All NIH awards
are subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement.

Pre-award
costs are allowable. A grantee may, at its own risk and without NIH prior
approval, incur obligations and expenditures to cover costs up to 90 days
before the beginning date of the initial budget period of a new award if such
costs: 1) are necessary to conduct the project, and 2) would be allowable under
the grant, if awarded, without NIH prior approval. If specific expenditures
would otherwise require prior approval, the grantee must obtain NIH approval
before incurring the cost. NIH prior approval is required for any costs to be
incurred more than 90 days before the beginning date of the initial budget
period of a new award.

The incurrence
of pre-award costs in anticipation of a competing or non-competing award
imposes no obligation on NIH either to make the award or to increase the amount
of the approved budget if an award is made for less than the amount anticipated
and is inadequate to cover the pre-award costs incurred. NIH expects the grantee
to be fully aware that pre-award costs result in borrowing against future
support and that such borrowing must not impair the grantee's ability to
accomplish the project objectives in the approved time frame or in any way
adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

PD/PI
Credential (e.g., Agency Login)

The NIH requires the
PD/PI to fill in his/her Commons User ID in the “PROFILE – Project
Director/Principal Investigator” section, “Credential” log-in field of the
“Research & Related Senior/Key Person Profile” component. The applicant
organization must include its DUNS number in its Organization Profile in the
eRA Commons. This DUNS number must match the DUNS number provided at CCR
registration with Grants.gov. For additional information, see “Registration
FAQs – Important Tips -- Electronic Submission of Grant Applications.”

Organizational DUNS

The
applicant organization must include its DUNS number in its Organization Profile
in the eRA Commons. This DUNS number must match the DUNS number provided at CCR
registration with Grants.gov. For additional information, see “Frequently Asked
Questions – Application Guide, Electronic Submission
of Grant Applications.”

PHS398 Research Plan Component
Sections

All
application instructions outlined in the SF424 (R&R) Application Guide are
to be followed, with the following requirements for R03 applications:

Introduction (required for a resubmission or
revision application) is limited to 1 page.

Specific Aims is limited to 1 page.

Research Strategy,
including tables, graphs, figures, diagrams, and charts, is limited to 6 pages.
See Table of Page Limits.

Preliminary data are not required but may be
included if available.

Budget Component

U.S. applicants submitting an application with direct costs in each year of $250,000
or less (excluding consortium Facilities and Administrative [F&A] costs)
must use the PHS398 Modular Budget component.

U.S. applicants requesting more than
$250,000 in annual direct costs and all foreign applicants must complete and
submit budget requests using the Research & Related Budget component.

R03
applications will use the modular budget and non-modular budget format (Foreign
organizations) and “Just-in-Time” information concepts, with direct costs
requested in up to two $25,000 modules, or $50,000 per year, for up to two
years (i.e., a maximum of $100,000 over two years in four modules of $25,000
each).

R03
Appendix materials may include ONLY pre-printed questionnaires or surveys. No
publications or figures are allowed in the Appendix.

Do not use the Appendix to
circumvent the page limitations. An application that does not observe these
limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH
considers the sharing of unique research resources developed through
NIH-sponsored research an important means to enhance the value and further the
advancement of the research. When resources have been developed with NIH funds
and the associated research findings published or provided to NIH, it is
important that they be made readily available for research purposes to
qualified individuals within the scientific community. If the final data/resources are not amenable to sharing,
this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).

(a) Data Sharing Plan: Not
Applicable

(b) Sharing Model Organisms:
Regardless of the amount requested, all applications where the development of
model organisms is anticipated are expectedto include a
description of a specific plan for sharing and distributing unique model
organisms and related resources, or state appropriate reasons why such sharing
is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless
of the amount requested, applicants seeking funding for a genome-wide
association study are expected to provide a plan for submission of GWAS data to the NIH-designatedGWAS data repository, or provide an appropriate
explanation why submission to the repository is not possible. A
genome-wide association study is defined as any study of genetic variation
across the entire genome that is designed to identify genetic associations with
observable traits (e.g., blood pressure or weight) or the presence or absence
of a disease or condition. For further information see Policy for Sharing
of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies
(go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)

Foreign Applications (Non-domestic [non-U.S.]
Entities)

Indicate
how the proposed project has specific relevance to the mission and objectives
of the NIH/IC and has the potential for significantly advancing the health
sciences in the United States

Section V. Application Review Information

1. Criteria

Only the review
criteria described below will be considered in the review process.

2.
Review and Selection Process

Review
Process

Applications
submitted for this funding opportunity will be assigned on the basis of
established PHS referral guidelines to the ICs for funding consideration.

Applications
that are complete will be evaluated for scientific and technical merit by an
appropriate scientific review group(s) in accordance
with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria
stated below.

Applications that are complete will be evaluated for
scientific and technical merit by an appropriate peer review group convened by CSRand
in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.

As
part of the initial merit review, all applications will:

Undergo
a selection process in which only those applications deemed to have the
highest scientific merit, generally the top half of applications under
review, will be discussed and assigned an impact/priority
score;

Receive a written critique; and

Receive a second level of review bythe appropriate national advisory council or board.

The mission of the NIH
is to support science in pursuit of knowledge about the biology and behavior of
living systems and to apply that knowledge to extend healthy life and reduce
the burdens of illness and disability. As part of this mission,
applications submitted to the NIH for grants or cooperative agreements to
support biomedical and behavioral research are evaluated for scientific and
technical merit through the NIH peer review system.

The
R03 small grant supports discrete, well-defined projects that realistically can
be completed in two years and that require limited levels of funding. Because
the research project usually is limited, an R03 grant application may not contain
extensive detail or discussion. Accordingly, reviewers should evaluate the
conceptual framework and general approach to the problem. Appropriate
justification for the proposed work can be provided through literature
citations, data from other sources, or from investigator-generated data.
Preliminary data are not required, particularly in applications proposing pilot
or feasibility studies.

Overall Impact

Reviewers will provide an overall impact/priority score
to reflect their assessment of the likelihood for the project to exert a
sustained, powerful influence on the research field(s) involved, in
consideration of the following five scored review criteria, and additional
review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the five review criteria
below in the determination of scientific and technical merit, and give a
separate score for each. An application does not need to be strong in all
categories to be judged likely to have major scientific impact. For
example, a project that by its nature is not innovative may be essential to
advance a field.

Significance. Does the project address
an important problem or a critical barrier to progress in the field? If
the aims of the project are achieved, how will scientific knowledge, technical
capability, and/or clinical practice be improved? How will successful
completion of the aims change the concepts, methods, technologies, treatments,
services, or preventative interventions that drive this field?

Investigator(s). Are the PD/PIs,
collaborators, and other researchers well suited to the project? If Early
Stage Investigators or New Investigators, or in the early stages of independent
careers, do they have appropriate experience and training? If
established, have they demonstrated an ongoing record of accomplishments that
have advanced their field(s)? If the project is collaborative or
multi-PD/PI, do the investigators have complementary and integrated expertise;
are their leadership approach, governance and organizational structure
appropriate for the project?

Innovation. Does the application
challenge and seek to shift current research or clinical practice paradigms by
utilizing novel theoretical concepts, approaches or methodologies, instrumentation,
or interventions? Are the concepts, approaches or methodologies,
instrumentation, or interventions novel to one field of research or novel in a
broad sense? Is a refinement, improvement, or new application of
theoretical concepts, approaches or methodologies, instrumentation, or
interventions proposed?

Approach. Are the overall strategy,
methodology, and analyses well-reasoned and appropriate to accomplish the
specific aims of the project? Are potential problems, alternative
strategies, and benchmarks for success presented? If the project is
in the early stages of development, will the strategy establish feasibility and
will particularly risky aspects be managed?

If the project involves clinical research, are the plans
for 1) protection of human subjects from research risks, and 2) inclusion of
minorities and members of both sexes/genders, as well as the inclusion of
children, justified in terms of the scientific goals and research strategy
proposed?

Environment. Will the scientific environment
in which the work will be done contribute to the probability of success?
Are the institutional support, equipment and other physical resources available
to the investigators adequate for the project proposed? Will the project
benefit from unique features of the scientific environment, subject
populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will
consider the following
additional items in the determination of scientific and technical merit, but
will not give separate scores for these items.

Protections for Human
Subjects. For
research that involves human subjects but does not involve one of the six
categories of research that are exempt under 45 CFR Part 46, the committee will
evaluate the justification for involvement of human subjects and the proposed
protections from research risk relating to their participation according to the
following five review criteria: 1) risk to subjects, 2) adequacy of protection
against risks, 3) potential benefits to the subjects and others, 4) importance
of the knowledge to be gained, and 5) data and safety monitoring for clinical
trials.

For research that involves human subjects and meets
the criteria for one or more of the six categories of research that are exempt
under 45 CFR Part 46, the committee will evaluate: 1) the justification for the
exemption, 2) human subjects involvement and characteristics, and 3) sources of
materials.

Inclusion of Women,
Minorities, and Children. When the proposed project involves clinical
research, the committee will evaluate the proposed plans for inclusion of
minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals. The committee will
evaluate the involvement of live vertebrate animals as part of the scientific
assessment according to the following five points: 1) proposed use of the
animals, and species, strains, ages, sex, and numbers to be used; 2)
justifications for the use of animals and for the appropriateness of the
species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for
limiting discomfort, distress, pain and injury to that which is unavoidable in
the conduct of scientifically sound research including the use of analgesic,
anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and
5) methods of euthanasia and reason for selection if not consistent with the
AVMA Guidelines on Euthanasia. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards. Reviewers will assess
whether materials or procedures proposed are potentially hazardous to research
personnel and/or the environment, and if needed, determine whether adequate
protection is proposed.

Resubmission
Applications.
When reviewing a Resubmission application (formerly called an amended
application), the committee will evaluate the application as now presented,
taking into consideration the responses to comments from the previous
scientific review group and changes made to the project.

Renewal Applications. Renewals are not allowed for this FOA.

Revision Applications. When reviewing a Revision application (formerly
called a competing supplement application), the committee will consider the
appropriateness of the proposed expansion of the scope of the project. If
the Revision application relates to a specific line of investigation presented
in the original application that was not recommended for approval by the
committee, then the committee will consider whether the responses to comments
from the previous scientific review group are adequate and whether substantial
changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will
address each of the following items, but will not give scores for these items
and should not consider them in providing an overall impact/priority score.

Applications from
Foreign Organizations. As
applicable for the FOA or submitted application, reviewers will assess whether
the project presents special opportunities for furthering research programs
through the use of unusual talent, resources, populations, or environmental
conditions that exist in other countries and either are not readily available
in the United States or augment existing U.S. resources.

Select Agents Research. Reviewers will assess the
information provided in this section of the application, including 1) the
Select Agent(s) to be used in the proposed research, 2) the registration status
of all entities where Select Agent(s) will be used, 3) the procedures that will
be used to monitor possession use and transfer of Select Agent(s), and 4) plans
for appropriate biosafety, biocontainment, and security of the Select Agent(s).

A formal notification in the form of a Notice
of Award (NoA) will be provided to the applicant organization. The NoA
signed by the grants management officer is the authorizing document. Once all
administrative and programmatic issues have been resolved, the NoA will be
generated via email notification from the awarding component to the grantee
business official.

Selection of an application for award is not an authorization
to begin performance. Any costs incurred before receipt of the NoA are at the
recipient's risk. These costs may be reimbursed only to the extent considered
allowable pre-award costs. See Section IV.5.,
“Funding Restrictions.”

2. Administrative and National Policy Requirements

The terms and conditions of the award may include specific
requirements for data and/or resource sharing including depositing cell lines,
DNA samples, biomaterials or other mouse and animal models into National repositories

A final progress report, invention statement,
and Financial Status Report are required when an award is relinquished when a
recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding
opportunity and welcome the opportunity to answer questions from potential
applicants. Inquiries may fall into three areas: scientific/research, peer
review, and financial or grants management issues:

Human Subjects
Protection:Federal regulations (45 CFR 46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety
Monitoring Plan:Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (Phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving interventions
that entail potential risks to the participants (“NIH Policy for Data and
Safety Monitoring,” NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing
Research Data:Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (http://grants.nih.gov/grants/policy/data_sharing).Investigators should seek
guidance from their institutions, on issues related to institutional policies
and local institutional review board (IRB) rules, as well as local, State and
Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide
Association Studies (GWAS):NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH
Guide NOT-OD-07-088. For additional information,
see http://grants.nih.gov/grants/gwas/

Sharing of Model Organisms:NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model
organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH
recognizes the rights of grantees and contractors to elect and retain title to
subject inventions developed with Federal funding pursuant to the Bayh-Dole Act
(see the NIH Grants Policy Statement. Beginning October 1, 2004,
all investigators submitting an NIH application or contract proposal are expected
to include in the application/proposal a description of a specific plan for
sharing and distributing unique model organism research resources generated
using NIH funding or state why such sharing is restricted or not possible. This
will permit other researchers to benefit from the resources developed with
public funding. The inclusion of a model organism sharing plan is not subject
to a cost threshold in any year and is expected to be included in all
applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of
Information Act:The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are: (1) first
produced in a project that is supported in whole or in part with Federal funds;
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to
place data collected under this funding opportunity in a public archive, which
can provide protections for the data and manage the distribution for an
indefinite period of time. If so, the application should include a description
of the archiving plan in the study design and include information about this in
the budget justification section of the application. In addition, applicants
should think about how to structure informed consent statements and other human
subjects procedures given the potential for wider use of data collected under
this award.

Inclusion of Women And Minorities in Clinical
Research:It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the
updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy
incorporates: the use of an NIH definition of clinical research; updated racial
and ethnic categories in compliance with the new OMB standards; clarification
of language governing NIH-defined Phase III clinical trials consistent with the
SF424 (R&R) application; and updated roles and responsibilities of NIH
staff and the extramural community. The policy continues to require for all
NIH-defined Phase III clinical trials that: a) all applications or proposals
and/or protocols must provide a description of plans to conduct analyses, as
appropriate, to address differences by sex/gender and/or racial/ethnic groups,
including subgroups if applicable; and b) investigators must report annual
accrual and progress in conducting analyses, as appropriate, by sex/gender
and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical
Research:The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.

Required Education on the Protection of Human Subject
Participants:NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators
funded by the NIH must submit or have submitted for them to the National
Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final,
peer-reviewed manuscripts upon acceptance for publication, to be made publicly
available no later than 12 months after the official date of publication. The
NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html).For more
information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable
Health Information:The Department
of Health and Human Services (HHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The Privacy
Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the HHS
Office for Civil Rights (OCR).

Decisions about
applicability and implementation of the Privacy Rule reside with the researcher
and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the
Privacy Rule, including a complete Regulation Text and a set of decision tools
on "Am I a covered entity?" Information on the impact of the HIPAA
Privacy Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts can be
found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs
in NIH Grant Applications or Appendices:
All applications and proposals
for NIH funding must be self-contained within specified page limitations. For
publications listed in the appendix and/or Progress report, Internet addresses
(URLs) or PubMed Central (PMC) submission identification numbers must be used
for publicly accessible on-line journal articles. Publicly accessible
on-line journal articles or PMC articles/manuscripts accepted for publication
that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference
in either the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant
application. A URL or PMC submission identification number citation may be repeated
in each of these sections as appropriate. There is no limit to the number of
URLs or PMC submission identification numbers that can be cited.

Healthy
People 2010:The Public
Health Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.

Authority and
Regulations:This program is described in
the Catalog of Federal Domestic Assistance athttp://www.cfda.gov/ and is not subject to the intergovernmental
review requirements of Executive Order 12372. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act as
amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and
45 CFR Parts 74 and 92. All awards are subject to the
terms and conditions, cost principles, and other considerations described in
the NIH Grants Policy
Statement.

The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.

Loan
Repayment Programs:NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov/.